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Astellas' Xospata becomes US-approved drug for FLT3-mutated acute myeloid leukaemia
pharmafile
November 30, 2018
Astellas has revealed that Xospata (gilteritinib) has been awarded FDA approval as a treatment for relapsed or refractory acute myeloid leukaemia (AML) with an FLT3 mutation – a first for the US regulator in this indication.
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FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation
fda
November 29, 2018
The FDA also approved an expanded indication for a companion diagnostic, to include use with Xospata. The LeukoStrat CDx FLT3 Mutation Assay, developed by Invivoscribe Technologies, Inc., is used to detect the FLT3 mutation in patients with AML.
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FDA Approves Xospata
drugs
November 29, 2018
FDA Approves Xospata (gilteritinib) for Acute Myeloid Leukemia (AML) with a FLT3 Mutation.
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Leukaemia combination therapy effective in Phase II trial
europeanpharmaceuticalreview
November 14, 2018
A Phase II clinical trial using combination therapy to treat leukaemia has shown positive results, with a Phase III clinical trial initiated…
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NICE recommends Vyxeos for specific secondary AML
biospectrumasia
November 12, 2018
Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine
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NICE recommends Jazz Pharmaceuticals’ Vyxeos to treat AML
pharmaceutical-technology
November 12, 2018
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Jazz Pharmaceuticals’ Vyxeos formulation to treat adults with two types of secondary Acute Myeloid Leukaemia (AML).
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NICE nod for Jazz’ AML chemo
pharmatimes
November 09, 2018
“I am pleased that NICE has recognised the value of this medicine for adults with secondary AML. In time, it is expected to become the standard of care for this specific group of older AML patients.”
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Chi-Med Initiates a Ph I Trial of HMPL-523 for AML
biospectrumasia
October 22, 2018
This study complements the ongoing Phase Ib dose expansion program of HMPL-523 in a broad range of hematological cancers in Australia.
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NICE expands backing for Pfizer’s Mylotarg
pharmatimes
October 11, 2018
NICE is recommending Mylotarg for previously untreated, de novo, CD33-positive acute myeloid leukaemia in combination with chemotherapy.
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FDA grants orphan drug status to ASLAN’s treatment for AML
biospectrumasia
August 21, 2018
ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be first-in-class in AML.